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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04325386
Other study ID # HP-00087399
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In a randomized controlled design with approximately 26 biweekly sessions over 12 months, the investigators propose to test the effectiveness of an ECHO-based intervention for improving the use of clozapine in people eligible for clozapine. The sessions will include: 1) active dissemination of knowledge and information by an expert "hub" followed by 2) clozapine case presentations and vignettes submitted by the "spokes". This intervention, Clozapine CHAMPION-ECHO (Center for Help and Assistance for Maryland Prescribers- Improving Outcomes Network using Extension for Community Healthcare Outcomes, will be referred to as "CHAMPION" throughout.. To minimize ANC monitoring barriers and maximize recruitment, the investigators will provide Food and Drug Administration (FDA)-cleared ANC point of care (POC) monitoring devices to all study sites, including those in the control condition. The investigators will enroll at least 300 prescribers and additional clinical team members (up to 300) from 60 outpatient mental health clinics (OMHCs) and other treatment sites; approximately half the OHMCs will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 85 Years
Eligibility Inclusion Criteria: - Located at a site in the State of Maryland with at least 3 prescribers at the site. - Prescribers/clinical team should be licensed in the State of Maryland and have prescribed antipsychotics previously. - Between the ages of 22 and 85 years old - Willing to participate in pre- and post-testing - Willing to agree to try to participate in the CHAMPION sessions Exclusion Criteria: - Not willing to participate in CHAMPION Sessions

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education Sessions
Project ECHO (Extension for Community Healthcare Outcomes) based intervention sessions for improving the use of clozapine in people with treatment-resistant schizophrenia. The sessions will include: 1) active dissemination of knowledge and information by an expert followed by 2) clozapine case presentations and vignettes.
No Education Session
No Education Session

Locations

Country Name City State
United States Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP) Catonsville Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in clozapine prescriptions using Medicaid claims data The data outcome is new clozapine prescriptions by provider based on a variable linking provider ID to clozapine prescriptions. The outcome is the increase in the proportion of patients treated with clozapine for those in the care of prescribers randomized to the CHAMPION relative to the ETAU condition. Baseline and endpoint changes after 12 month intervention
Primary Change in prescriber knowledge of clozapine use A 52 item Multiple Choice Questionnaire will be used to assess knowledge. The knowledge-based test questions will consist of 2 questions per 26 topic areas and will conform to best practices and guidelines for design of the questions. The total mean score will range from 0-52. The questions were developed and validated by the team. Baseline and endpoint changes after 12 month intervention
Primary Change in self-reported competence for clozapine use We will use a mean score on a Visual Analog Scale (VAS) (0-100 mm). We will have one for overall competence and then one for each of the 26 topic areas. Overall, self report scores and the global self report scores will be used. Baseline and endpoint changes after 12 month intervention
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